Actively Recruiting
A Phase I/II Study to Determine the Safety and Efficacy of a Combination of Green Tea and Quercetin With Docetaxel in Castration-resistant Prostate Cancer Patients
Led by Charles Drew University of Medicine and Science · Updated on 2026-04-15
99
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
C
Charles Drew University of Medicine and Science
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding natural products green tea and quercetin to docetaxel chemotherapy improves treatment for advanced prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). The study also aims to assess the safety of combining these supplements with docetaxel. This is a Phase I/II randomized clinical trial sponsored by Charles Drew University of Medicine and Science. Participants will receive either green tea and quercetin capsules along with docetaxel chemotherapy or placebo capsules with docetaxel for comparison. The treatments are given in cycles, and the study is designed to compare how the supplements affect the therapy's effectiveness and safety. The trial uses a quadruple masking method to protect unbiased results. During the study, researchers will monitor participants by measuring blood prostate specific antigen (PSA) levels from enrollment until 11 weeks, along with tumor DNA levels, tumor size via CT scans, and side effects using standard criteria. Blood levels of green tea, quercetin, and docetaxel will also be analyzed on the first day of the first treatment cycle. The total duration of treatment and assessments is approximately 11 weeks.
CONDITIONS
Brief Title
Green Tea and Quercetin in Combination With Docetaxel Chemotherapy in Castration-resistant Prostate Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form and HIPPA authorization
- Willingness to comply with all study procedures and availability for the entire study duration
- Male patients aged 18 years or older
- Diagnosed with metastatic prostate cancer
- History of confirmed progressive disease with ongoing medical or surgical castration
- Confirmed progressive disease while using enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate
- Clinical decision to start docetaxel infusion with prednisone treatment
- Adequate bone marrow function (ANC > 1500 cells/mm³, platelets > 100,000 cells/mm³)
- Adequate liver function (total bilirubin below upper limit of normal, ALT and AST less than 1.5 times upper limit of normal)
- Adequate kidney function (normal serum creatinine levels)
- Expected life expectancy of at least 6 months
- Willing to stop consuming tea or quercetin supplements except those provided by the study during the intervention period
You will not qualify if you...
- Prior chemotherapy or radiotherapy for metastatic disease
- Any health condition preventing administration of docetaxel/prednisone
- Ongoing alcohol abuse
- Significant medical or psychiatric conditions making participation unsuitable
- Prior allergic reactions to tea, tea products, or quercetin supplements
- Allergies to multiple foods or nutritional supplements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 11 weeks
Participants receive green tea and quercetin supplements or placebo capsules in combination with docetaxel chemotherapy.
Weekly visits during 3 cycles of treatment (each cycle is 21 days)
Trial Site Locations
Total: 1 location
1
Charles R. Drew University of Medicine and Science
Los Angeles, California, United States, 90059
Actively Recruiting
Research Team
P
Piwen Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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